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Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.

Oct 29, 2014 10/14

by Gluud, Christian; Kubiak, Christine; Whitfield, Kate; Byrne, Jane; Huemer, Karl-Heinz; Thirstrup, Steffen; Libersa, Christian; Barraud, Beatrice; Grahlert, Xina; Dreier, Gabriele; Geismann, Sebastian; Kuchinke, Wolfgang; Temesvari, Zsuza; Blasko, Gyorgy; Kardos, Gabriella; O'Brien, Timothy; Cooney, Margaret; Gaynor, Siobhan; Schieppati, Arrigo; de Andres, Fernando; Sanz, Nuria; Kreis, German; Asker-Hagelberg, Charlotte; Johansson, Hanna; Bourne, Sue; Asghar, Adeeba; Husson, Jean-Marc; Demotes-Mainard, Jacques

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This article is from Trials , volume 13 . Abstract Background: In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods: We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN)...
Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338370

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Complete genome and comparative analysis of Streptococcus gallolyticus subsp. gallolyticus, an emerging pathogen of infective endocarditis.

Oct 28, 2014 10/14

by Hinse, Dennis; Vollmer, Tanja; Ruckert, Christian; Blom, Jochen; Kalinowski, Jorn; Knabbe, Cornelius; Dreier, Jens

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This article is from BMC Genomics , volume 12 . Abstract Background: Streptococcus gallolyticus subsp. gallolyticus is an important causative agent of infectious endocarditis, while the pathogenicity of this species is widely unclear. To gain insight into the pathomechanisms and the underlying genetic elements for lateral gene transfer, we sequenced the entire genome of this pathogen. Results: We sequenced the whole genome of S. gallolyticus subsp. gallolyticus strain ATCC BAA-2069, consisting...
Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173452

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